Search Results

The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Subject of this premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively.

Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-6Al-7Nb titanium alloy according to ASTM F1295-05 and ISO 5832-11. The primary stem SL-PLUS is available in 14 size options.

The SL-PLUS lateralized version is an additional 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS Stem, thus giving the surgeon a further option to meet the patient's anatomy. The Caput Collum Diaphysis (CCD) angle is 123° compared to 131° for the standard SL-PLUS Stem. The material and surface characteristics remain unchanged for the lateralized stem as compared to the standard stem.

The provided text is a 510(k) summary for the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials and specific performance metrics with acceptance criteria, which is more common for novel or high-risk devices.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, or a study proving it meets such criteria in the way you've outlined. Instead, it focuses on comparing the new device to existing, cleared devices.

Here's a breakdown of what can be extracted and what is not present in relation to your questions:

1. A table of acceptance criteria and the reported device performance:

• Not present. This document does not list specific acceptance criteria (e.g., success rates, failure rates, specific measurement tolerances) or quantitative performance data from a dedicated study of the device. The "performance" is implicitly tied to its substantial equivalence to predicate devices that have already demonstrated safety and effectiveness.

2. Sample size used for the test set and the data provenance:

• Not present. There is no mention of a "test set" in the context of a study with human subjects, nor any data provenance, as this submission relies on equivalence to existing devices rather than a de novo clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not present. No ground truth establishment using experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not present. This is a hip stem, not an AI diagnostic device. There is no mention of human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not present. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not present. The concept of "ground truth" as it applies to clinical diagnostics or AI performance studies is not relevant here. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not present. There is no mention of a "training set" as this is not a machine learning device or a clinical study that would involve such.

9. How the ground truth for the training set was established:

• Not present.

Summary of what the document does provide regarding "performance" and "evaluation":

The "study" proving the device meets criteria is primarily a comparative analysis for substantial equivalence.

• Substantial Equivalence Information: The submission states that the "overall designs and the indications for use for the Smith & Nephew SL PLUS Standard and Lateral Femoral Stem are substantially equivalent to the PLUS Orthopedics SL-Plus and SL-Plus Lateralized Stems cleared for market under 510(k) Notifications K001942 and K021178, respectively."
• Technological Comparison: The document explicitly states: "The intended use, design, and materials of the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are substantially equivalent to the previously cleared PLUS Orthopedics SL-Plus and SLR-Plus, and the SL-PLUS Lateralized Stems (K001942 & K021178). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This means the "acceptance criteria" are effectively the characteristics and performance of the predicate devices (K001942 and K021178), and the "study" is the demonstration that the new device is sufficiently similar in terms of design, materials, and intended use, and has undergone internal "Design Control Activities" to ensure safety and effectiveness comparable to the predicates. Specific quantitative performance metrics are not typically required for this type of 510(k) submission where substantial equivalence to a well-established device type is being claimed.

Ask a specific question about this device

The MPF Acetabular Cup is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

The MPF Acetabular Cup is a cementless, press-fit cup. It is available in 10 sizes ranging from 46 mm to 64 mm in 2 mm increments. It is manufactured from CP Titanium according to ASTM F 67. UHMWPE inserts are available in neutral and 20° hooded versions. Cancellous bone screws manufactured from Ti6Al4V are available in 7 sizes ranging from 20 mm to 50 mm in length. They have a standard 6.5 mm thread diameter. The cup has 3 screw holes for optional fixation. The open, unused screw holes can be closed with threaded screw hole covers. The MPF cup may be used with the following ball heads manufactured by PLUS and INTRAPLANT that are cleared for marketing by the U.S. FDA: CS-PLUS® Stem with CoCrMo Ball Head (K936214 - 6/15/94) SL/SLR-PLUS® Stem with CoCrMo Ball Head (K932481 - 6/8/94) SL/SLR-PLUS® Stem with Biolox Ceramic Head (K930963 - 17794) INTRAPLANT Ceramic Ball Heads (K990261 - 8/27/99) MODULAR-PLUS® Revision Stem (K994126 - 5/4/00) PLUS CoCrMo Ball Heads (K001942 - 7/25/00)

The provided 510(k) summary (K011836) for the MPF Acetabular Cup is for a medical device that replaces part of a hip joint. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical study or complex algorithm validation. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the context of this 510(k) submission. The document states:

Note: For medical devices cleared via 510(k), especially for implants like this, the focus is often on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting novel performance criteria established through efficacy studies. Performance is often assessed through bench testing (biomechanical, material compatibility, etc.) and comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device relies on biomechanical testing and comparison to a predicate, not a clinical "test set" in the context of algorithm performance or clinical trial data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of clinical expert consensus for image analysis or diagnostic algorithms is not relevant for this device. The regulatory review process involves FDA experts, but that's a different context.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of clinical cases requiring adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned and is typically not applicable for a hip replacement component. This type of study is more common for diagnostic imaging algorithms.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (an acetabular cup for hip replacement), not a software algorithm.

7. Type of Ground Truth Used

For the biomechanical tests, the "ground truth" would be established by engineering standards and accepted biomechanical principles for orthopedic implants (e.g., ability to withstand physiological loads, fatigue resistance, material properties meeting ASTM standards).

For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or algorithms for this device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Ask a specific question about this device

The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Zirconia ceramic heads for use with Foundation® Forged (K952191), Textured (K935263) and Porous Stems (K952297), the Encore® Vitality™ Stem (K962560) and the SL and SLR PLUS (K932481) Hip Stems which have been cleared for commercial distribution.

This document is a 510(k) premarket notification for a medical device: Zirconia ceramic femoral heads for use with specific hip stems. The content is primarily a summary of safety and effectiveness used to demonstrate substantial equivalence to predicate devices, rather than a detailed study report with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth cannot be fully extracted from the provided text. The document focuses on demonstrating that the new Zirconia ceramic heads are comparable in material, design, and clinical indications to existing, cleared devices.

Based on the provided text, the following information can be stated:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The filing is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with detailed performance metrics.
• Sample Size Used for the Test Set and Data Provenance: Not applicable. This document is not a report of a clinical trial or a test set evaluation. It's a regulatory submission demonstrating equivalence.
• Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable. This document does not describe a ground truth establishment process for a test set.
• Adjudication Method for the Test Set: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (femoral head), not an algorithm or AI system.
• The type of ground truth used: Not applicable in the context of an AI/algorithm. For a physical device, "ground truth" would relate to material properties, wear performance, or clinical outcomes, which are not detailed as a "ground truth" for a specific test set in this document. The "truth" in this context is established through a body of evidence including material testing and comparable clinical performance of predicate devices.
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Summary of the document's relevance to the request:

The document outlines an intention to market Zirconia ceramic heads for hip replacement prostheses. The core of the submission is to establish substantial equivalence to predicate devices. This means that instead of presenting a new study with explicit acceptance criteria for performance, the submission argues that the device is "equivalent in material, design and clinical indications" to already cleared devices. This equivalency is the "proof" that the device meets regulatory requirements.

The predicate devices mentioned are Zirconia heads manufactured by Demarquest for Zimmer (K944601), DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). The "acceptance criteria" are effectively that the new device performs sufficiently similar to these cleared predicate devices according to established material and design standards for hip prostheses.

Ask a specific question about this device